Marcaine

(Bupivacaine)

ApprovedSmall molecule

Bupivacaine is a local anesthetic used to numb specific areas of the body during medical procedures or surgery, and can also be used to relieve pain after surgery or for chronic pain conditions.[2] Marcaine is currently approved and in use across 119 indications[4].[1]

Marcaine is one of 1442 small molecule programs targeting Plantar Fasciitis. It is currently in Approved.

119

Indications

618

Total Trials

Active Trials

1,441

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Plantar FasciitisApproved

Congenital Hip DislocationActive, not recruiting

Ventral HerniaApproved

Pancreatic NeoplasmApproved

Peritoneum CancerApproved

Myofascial Pain SyndromeActive, not recruiting

Cleft PalateActive, not recruiting

Chronic PancreatitisApproved

Neuropathic PainActive, not recruiting

Low Back PainApproved

Plantar FasciitisApproved

Approved

Congenital Hip DislocationPreclinical

Active, not recruiting

Ventral HerniaApproved

Approved

Pancreatic NeoplasmApproved

Approved

Peritoneum CancerApproved

Approved

Myofascial Pain SyndromePreclinical

Active, not recruiting

Cleft PalatePhase 2

Active, not recruiting

Chronic PancreatitisApproved

Approved

Neuropathic PainPhase 3

Active, not recruiting

Low Back PainApproved

Approved

Showing 10 of 111 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Marcaine

IInnocoll

Approved

2 2

Trodelvy

Gilead

Preclinical

37 3

Halaven

Eisai

Preclinical

38 4

Tecentriq

Roche

Preclinical

36 5

Megace

Bristol-Myers Squibb

Preclinical

4 6

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 7

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 8

Aquasol E

NNational Eye Institute (NEI)

Preclinical

—9

QS21

MMemorial Sloan Kettering Cancer Center

Preclinical

3 10

Dextromethorphan Hydrobromide

Boehringer Ingelheim

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Post-ApprovalRecruiting

Liposomal Bupivacaine

NCT03737292

Phase 2Recruiting

Bupivacaine

NCT07465185

Q1 2027

N/ARecruiting

Peripheral Nerve Stimulation

NCT06004882

Q2 2027

Phase 3Not yet recruiting

Post Operative Pain

NCT06789575

Post-ApprovalRecruiting

Interscalene Block

NCT06143306

Q3 2027

Phase 1Active, not recruiting

Analgesia

NCT04126824

Clinical

Trials by Indication[1]

Liposomal Bupivacaine12 trials

Liposomal Bupivacaine Interscalene Blocks for Rotator Cuff Repair

Completed·UUniversity of Minnesota·Phase 4·NCT03587584·80 enrolled

Liposomal Bupivacaine for Pain Control Following Thoracic Surgery.

Unknown status·MMassachusetts General Hospital·Phase 2/3·NCT03036085·200 enrolled

TAP Block With Liposomal Bupivacaine Versus Pre-incisional Wound Infiltration With Bupivacaine for Postoperative Pain

Terminated·UUniversity of Tennessee·Phase 1·NCT02400645·69 enrolled

Show 9 more trials

The Effect of Liposomal Bupivacaine on Post Operative Pain and Narcotic Use After Bariatric Surgery

Completed·UUniversity of California, San Francisco·Phase 4·NCT03196505·231 enrolled

Rectus Sheath Block With Liposomal Bupivacaine Versus Thoracic Epidural Analgesia for Pain Control Following Pancreatoduodenectomy

Recruiting·MMasonic Cancer Center, University of Minnesota·Phase 2·NCT06411795·78 enrolled

Pilot Study of Liposomal Bupivacaine Redosing in Patients Undergoing Major Gynecologic Procedures

Terminated·UUniversity of California, Irvine·Phase 3·NCT04849858·13 enrolled

Liposomal Bupivacaine vs Bupivacaine for Pain Control After Sternotomy

Unknown status·UUniversity of Kansas Medical Center·Phase 1·NCT04585867·80 enrolled

Liposomal Bupivacaine Versus Plain Bupivacaine After Intercostal Injections For Pain Management After Thoracoscopy

Recruiting·MMilton S. Hershey Medical Center·Phase 4·NCT03737292·40 enrolled

Standard Bupivacaine vs Liposomal Bupivacaine in Colorectal Patients

Terminated·IInova Health Care Services·Phase 4·NCT03638635·63 enrolled

The Use Of Liposomal Bupivacaine For Pain Control

Completed·WWake Forest University Health Sciences·Phase 4·NCT03722927·3 enrolled

Comparison of Analgesic Efficacy Between of Interscalene Block With Liposomal Bupivacaine With Bupivacaine and Dexamethasone

Completed·IIcahn School of Medicine at Mount Sinai··NCT03969875·90 enrolled

Efficacy of Liposomal Bupivacaine for Pain Control After Percutaneous Nephrostolithotomy

Withdrawn·NNorthwell Health·Phase 3·NCT03043027

Bupivacaine9 trials

Comparing Ropivacaine and Bupivacaine in DTFNB Anesthesia in Patients Undergoing Phacoemulsification

Completed·GGovernment Medical College, Haldwani·N/A·NCT02925832·100 enrolled

Comparative Mixture of Non-racemic and Racemic Enantiomers of Bupivacaine in Cesarean

Withdrawn·CCristália Produtos Químicos Farmacêuticos Ltda.·Phase 3·NCT01303107

Intrathecal Bupivacaine With or Without Dexmetomidine for Cesserian Delivery

Recruiting·—·Phase 2·NCT07465185·300 enrolled

Show 6 more trials

Use of Continuous Wound Infusion of Bupivacaine for Analgesia Following Axillary Clearance Surgery

Unknown status·—·Phase 3·NCT01314144·42 enrolled

Ropivacaine Versus Bupivacaine for Spinal Anaesthesia in Patients Undergoing Unilateral Lower Limb Surgery

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00358280·220 enrolled

Continuous Bupivacaine Infusion Following Colonic Surgery

Withdrawn·TThe Cleveland Clinic·N/A·NCT00557843

Effects of Thoracic Epidural Administered Ropivacaine Versus Bupivacaine on Bladder Function

Completed·IInsel Gruppe AG, University Hospital Bern·Phase 4·NCT02414373·42 enrolled

Comparison of Levobupivacaine, Ropivacaine and Bupivacaine in Epidural Anaesthesia

Completed·GGovernment Medical College, Haldwani·N/A·NCT02513433·90 enrolled

Continuous Subacromial Bupivacaine

Completed·TTurku University Hospital·N/A·NCT01377415·90 enrolled

Total Knee Arthroplasty7 trials

Continuous Adductor Canal Blocks Vs. Low Dose Femoral Nerve Blocks For Early Rehabilitation After Total Knee Arthroplasty

Completed·—·Phase 4·NCT02453321·62 enrolled

Mepivacaine vs. Bupivacaine Spinal Anesthetic in Total Knee Arthroplasty

Completed·HHenry Ford Health System·Phase 4·NCT02980926·32 enrolled

Efficacy of Ipack Block and Surgeon's Joint Infiltration in Total Knee Arthroplasty

Completed·IIcahn School of Medicine at Mount Sinai·Phase 4·NCT03653416·99 enrolled

Show 4 more trials

Local Infiltration Analgesia With and Without EXPAREL Following Total Knee Arthroplasty

Completed· Pacira Pharmaceuticals, Inc logo

Pacira Pharmaceuticals, Inc·Phase 4·NCT02713490·140 enrolled

Efficacy of Multimodal Peri- and Intraarticular Drug Injections in Total Knee Arthroplasty

Completed·—·Phase 4·NCT00562627·102 enrolled

Single Injection Adductor Canal Block vs Catheter for Total Knee Arthroplasty

Completed·UUniversity of British Columbia·Phase 4·NCT02798835·180 enrolled

Pain Control After Total Knee Arthroplasty: Benefit In Adding Single Shot Adductor Canal Block to Existing Pain Regimen Protocol?

Completed·HHenry Ford Health System·Phase 1·NCT02740192·128 enrolled

Dexamethasone7 trials

Effect of Dexamethasone Added To Bupivacaine During Caudal Block

Unknown status·LLagos State University·Phase 2·NCT02496299·96 enrolled

REDUCE Trial: Perineural Dexamethasone on Scalp Nerve Blocks

Completed·—·N/A·NCT04648358·156 enrolled

Dexamethasone & Ketamine as Adjuvants to Bupivacaine for Incisional Infiltration in Pediatric Abdominal Operations

Completed·—·N/A·NCT05190952·150 enrolled

Show 4 more trials

Interscalene Nerve Blocks With Ropivacaine Alone, With Dexamethasone, Plus Systemic Dexamethasone

Terminated·TThe Cleveland Clinic·N/A·NCT00519584·218 enrolled

Effect of Dexamethasone on Duration of Lower Extremity Blocks With Bupivacaine in Subjects Having ACL Repair

Terminated·UUniversity of Chicago·Phase 4·NCT01756560·2 enrolled

Dexamethasone and Block Duration in Upper Extremity

Terminated·UUniversity of Chicago·N/A·NCT01756573·5 enrolled

The Effect of Dexamethasone on the Duration of Interscalene Nerve Blocks With Ropivacaine or Bupivacaine

Terminated·TThe Cleveland Clinic·N/A·NCT00801138·218 enrolled

Nerve Block6 trials

Opioid Use in Single Shot Nerve Block vs Continuous Peripheral Nerve Infusion in Anterior Cruciate Ligament (ACL) Repair

Terminated·—·Phase 3·NCT02075411·1 enrolled

A Study Comparing Continuous Sciatic Nerve Block to Single Shot Sciatic Nerve Block

Terminated·NNorthwestern University·Phase 4·NCT01615939·17 enrolled

The Use of Bupivacaine and Ropivacaine for Sciatic Nerve Block

Completed·NNorthwestern University·Phase 4·NCT01272921·142 enrolled

Show 3 more trials

Application of Combined Lumbar Plexus and Sciatic Nerve Block

Completed·GGuangzhou General Hospital of Guangzhou Military Command·Phase 4·NCT02084368·34 enrolled

Onset and Duration of Forearm Nerve Blockade

Completed·NNew York School of Regional Anesthesia·Phase 4·NCT03649763·36 enrolled

Bubiket Study: Ultrasound Guided Fascia Iliaca Nerve Block With Bupivacaine and Adjuvant Ketamine vs. Bupivacaine Alone

Withdrawn·AAntonios Likourezos·Phase 4·NCT03909594

111 more indications

Post Operative Pain6 trials

Comparison of Bupivacaine Wound Infiltration Versus Wound Instillation to Minimize Postoperative Pain After Thyroid Surgery

Not yet recruiting·—·Phase 3·NCT06789575·102 enrolled

Effect of Intrathecal vs Intraarticular Dexmedetomidine on Postoperative Pain Following Arthroscopy

Completed·—·N/A·NCT02581566·90 enrolled

The Effect of Intraperitoneal Instillation of Bupivacaine on Postoperative Pain After Surgical Laparoscopy

Completed·—·Phase 3·NCT06616441·80 enrolled

Show 3 more trials

Effect of Paracervical Block on Post Operative Pain in Laparoscopic Gynecologic Surgery

Completed·IIcahn School of Medicine at Mount Sinai·N/A·NCT01534416·132 enrolled

Efficacy of Exparel (TM) on Post-operative Pain After Laparoscopic Gastric Bypass Using Circular EEA Stapler

Completed·MMatthew Kroh·Phase 4·NCT03187379·102 enrolled

A Trial of Levator Muscle Blocks Following Posterior Colporrhaphy Surgery to Reduce Post-operative Pain.

Unknown status·TThe Christ Hospital·N/A·NCT03067168·128 enrolled

Local Anesthetic5 trials

Effects of Epidural Local Anesthetics on Propofol Induction

Completed·FFirst Hospital of China Medical University·Phase 4·NCT02000973·80 enrolled

Laparoscopic vs Ultrasound-Guided Transversus Abdominis Plane Block vs Laparoscopic Intraperitoneal Instillation of Local Anesthetic in Pediatrics

Completed·TTanta University·N/A·NCT06098105·66 enrolled

Minimum Local Anesthetic Volume of Bupivacaine in Labour Epidurals

Completed·SSamuel Lunenfeld Research Institute, Mount Sinai Hospital·N/A·NCT00450099·50 enrolled

Show 2 more trials

Transversus Abdominis Plane (TAP) Versus Local Anesthetic for Lap Appendectomies

Terminated·NNationwide Children's Hospital·Phase 2·NCT01575028·3 enrolled

Comparing the Efficacy of Local Anesthetics in Mohs Surgery

Unknown status·OOttawa Hospital Research Institute·N/A·NCT03871478·105 enrolled

Cesarean Delivery4 trials

Phenylephrine Infusion in Cesarean Delivery

Unknown status·—·Phase 4·NCT03248817·255 enrolled

Three Protocols for Phenylephrine Administration in Cesarean Delivery

Completed·—·Phase 4·NCT03302039·217 enrolled

Bupivacaine 5 mg vs 7.5 mg for Spinal Anesthesia in Cesarean Delivery in Indonesian Population

Completed·IIndonesia University·N/A·NCT03834454·112 enrolled

Show 1 more trial

Postoperative Cesarean Delivery Pain Relief; Diclofenac Versus Bupivacaine

Completed·DDepartment of Medical Services Ministry of Public Health of Thailand·Phase 4·NCT03039426·120 enrolled

Spinal Anesthesia4 trials

Phase III, Evaluate Noninferiority Between Levobupivacaine and Bupivacaine in Spinal Anesthesia.

Withdrawn·CCristália Produtos Químicos Farmacêuticos Ltda.·Phase 3·NCT01994967

Discharge Conditions of Spinal Anesthesia With Heavy Prilocaine-Fentanyl and Heavy Bupivacaine-Fentanyl

Completed·—·Phase 4·NCT01880775·50 enrolled

Spinal Anesthesia for Outpatient Abdominal Wall Surgery: Comparison of Bupivacaine, 2-chloroprocaine and Prilocaine

Completed·AAZ St.-Dimpna Geel··NCT02813382·101 enrolled

Show 1 more trial

Local Anesthetic Infiltration VS Trasversalis Fascia Block VS Spinal Anesthesia

Unknown status·IIstituti Ospitalieri di Cremona·N/A·NCT03128216·48 enrolled

Erector Spinae Plane Block4 trials

Erector Spinae Plane Block Versus Thoracic Epidural Block for Chest Trauma

Completed·SSameh Fathy·N/A·NCT03797079·50 enrolled

Dexamethasone Versus Magnesium Sulphate as an Adjuvant to Bupivacaine in Ultrasound Guided Erector Spinae Plane Block for Postoperative Analgesia in Elective Caesarean Section Under Spinal Anesthesia

Recruiting·—·N/A·NCT07139522·150 enrolled

Inter-semispinal Fascial Plane Block (ISPB) Versus Erector Spinae Plane Block (ESPB) in Posterior Cervical Spine Surgery

Active, not recruiting·FFayoum University·Phase 4·NCT07340801·102 enrolled

Show 1 more trial

U/s Guided Oblique Subcostal Transversus Abdominis Plane Block Versus Erector Spinae Plane Block as Preemptive Analgesia

Completed·—·Phase 4·NCT04941170·70 enrolled

Dexmedetomidine4 trials

Comparative Study Between the Effect of Dexmedetomidine ,Midazolam or Bupivacaine Packing During FESS on Surgical Field Visualization

Enrolling by invitation·MMinia University·Phase 3·NCT07013955·144 enrolled

Evaluation of the Analgesic Effect of Dexmedetomidine Versus Fentanyl as Adjuvants to Epidural Bupivacaine in Patients Undergoing Lumbar Spine Surgeries

Completed·—·N/A·NCT03463083·60 enrolled

Intraperitoneal Dexmedetomidine for Post-laparoscopic Appendicectomy Pain Management in Children

Unknown status·ZZagazig University·Phase 4·NCT03067740·56 enrolled

Show 1 more trial

Dexmedetomidine as an Additive for (Ipack)Block in Knee Surgery

Completed·—·N/A·NCT07058493·40 enrolled

Postoperative Pain Control3 trials

Bupivacaine Supplementation For Postoperative Pain Control In Surgical Removal Of Mandibular Third Molars

Unknown status·CCosmozone Dental Clinic·N/A·NCT02353676·100 enrolled

Postoperative Pain Control After Hip Hemiarthroplasty: Intrathecal Morphine vs Periarticular Infiltration of Bupivacaine

Terminated·MMahidol University·Phase 4·NCT01219062·10 enrolled

Added Value of Local Clonidine for Spine Postoperative Pain Control, in Addition to Bupivacaine

Completed·SSt Joseph University, Beirut, Lebanon·Phase 4·NCT01902108·225 enrolled

Hysterectomy3 trials

TAP Block With Liposomal Bupivacaine Versus Bupivacaine in Robotic Hysterectomy

Completed·UUniversity of Minnesota·Phase 4·NCT02289079·60 enrolled

Role of Dexamethasone for Erector Spinae Plane Block in Patients Undergoing Total Abdominal Hysterectomy

Completed·—·N/A·NCT03769818·150 enrolled

The Effect of Pre-sacral Nerve Block on Immediate Post-operative Pain Following Laparoscopic Hysterectomy.

Unknown status·MMount Sinai Hospital, Canada·Phase 4·NCT03646006·60 enrolled

Postoperative Analgesia3 trials

A Comparison of Bupivacaine and Ketorolac for Postoperative Analgesia After Iliac Crest Bone Harvesting

Completed·TThe Hospital for Sick Children·Phase 3·NCT00405262·54 enrolled

Laparoscopic Guided Transversus Abdominis Plane Block for Postoperative Analgesia After Pediatric Laparoscopic Surgery.

Unknown status·—·Phase 2/3·NCT03388671·44 enrolled

Effect of Caudal Nalbuphine on Postoperative Analgesia in Children

Completed·—·N/A·NCT02618876·60 enrolled

Interscalene Block3 trials

Addition of a Pectoserratus Block to Interscalene Block in Patients Undergoing Total Shoulder Replacement

Recruiting·UUniversity of Minnesota·Phase 4·NCT06143306·110 enrolled

is There an Alternative to Ultrasound Guided Interscalene Block?

Unknown status·TTunisian Military Hospital·N/A·NCT02397330·60 enrolled

Effect of Dexamethasone Dose and Route on Duration of Interscalene Block After Outpatient Shoulder Surgery

Completed·UUniversity of Manitoba·Phase 4·NCT02426736·280 enrolled

Laparoscopic Cholecystectomy3 trials

To Evaluate the Effect of Wound Infiltration With Bupivacaine for Post-operative Pain Relief After Laparoscopic Cholecystectomy

Completed·—·Phase 2·NCT03958513·58 enrolled

Dexmedetomidine Versus Magnesium Sulfate as Adjuvants to Intraperitoneal Bupivacaine for Postoperative Analgesia After Elective Laparoscopic Cholecystectomy

Completed·TTanta University·N/A·NCT06879288·75 enrolled

Dexmedetomidine as an Adjuvant to Bupivacaine in Ultrasound-Guided Quadratus Lumborum Block for Postoperative Analgesia in Laparoscopic Cholecystectomy

Completed·TTanta University·N/A·NCT06825286·90 enrolled

Analgesia2 trials

Effect of Addition of Steroids on Duration of Analgesia

Active, not recruiting·UUniversity of California, Los Angeles·Phase 1·NCT04126824·28 enrolled

A Comparison of Epidural Techniques for Labour Analgesia

Completed·UUniversity of British Columbia·N/A·NCT03065569·150 enrolled

Analgesic Efficacy2 trials

The Analgesic Efficacy of Two Bupivacaine Concentrations for Combined Ilioinguinal and Iliohypogastric Nerve Block in Postherniorrhaphy Pain

Unknown status·TTanta University·Phase 1·NCT05687981·90 enrolled

Analgesic Efficacy of Two Concentrations of Bupivacaine in Women in Labor

Completed·CCoordinación de Investigación en Salud, Mexico·Phase 4·NCT02244086·114 enrolled

Concentration2 trials

Efficacy of Popliteal Block and Bupivacaine Concentration Used for Analgesia in Foot and Ankle Surgery

Completed·—·Phase 4·NCT04294732·68 enrolled

Evaluation of the Minimum Effective Concentration of Bupivacaine (EC50) in Femoral Block for Analgesia by Ultrasound After Knee Surgery

Completed·EEd Carlos Rey Moura·Phase 4·NCT02124005·45 enrolled

Quadratus Lumborum Block2 trials

Quadratus Lumborum Block vs Transversus Abdominis Plane Block for Post-prostatectomy Analgesia

Terminated·JJagiellonian University·N/A·NCT03606889·12 enrolled

Pre-emptive Quadratus Lumborum Block for Laparoscopic Bariatric Surgery

Completed·—·N/A·NCT04294329·30 enrolled

Surgery2 trials

Efficiency of Thoracolumbar Interfascial Plane Block in Lumbar Disk Surgery

Unknown status·—·Phase 4·NCT03180099·50 enrolled

Serratus Plane Block For Breast Reduction Surgery

Completed·—·Phase 4·NCT02930733·40 enrolled

Mastectomy2 trials

Adding Magnesium Sulfate to Local Anesthetic in Combined Pectoral Nerve and Stellate Ganglion Block for Postoperative Pain Control After Modified Radical Mastectomy

Recruiting·—·N/A·NCT06815887·70 enrolled

Ultrasound-guided Paravertebral Block Versus Mid-point Transverse Process Pleura Block in Mastectomy Surgery

Completed·—·Phase 4·NCT05332028·64 enrolled

Colorectal Surgery2 trials

Evaluation of a TAP Block Given During Laparoscopic Colorectal Surgery to Help Control Pain

Completed·UUniversity Hospitals Cleveland Medical Center·N/A·NCT01731782·79 enrolled

Pain Relief After Colorectal Surgery: Spinal Combined With Painbuster® vs Painbuster® Alone.

Completed·YYork Teaching Hospitals NHS Foundation Trust·N/A·NCT02210260·79 enrolled

Amputation2 trials

Epidural Oxycodone for Pain Management for Lower Limb Amputation

Unknown status·KKafrelsheikh University·N/A·NCT06276179·40 enrolled

Peripheral Nerve Blocks for Major Lower Extremity Amputations

Terminated·UUniversity of California, San Francisco·Phase 4·NCT03174782·42 enrolled

Ultrasound2 trials

Comparing Analgesic Effects of Three Ultrasound Guided Regional Anesthetic Techniques in Pediatrics

Completed·IIstanbul University·N/A·NCT03780790·135 enrolled

Comparison of Quality of Supraclavicular, Infraclavicular and Axillary Approach of Ultrasound-guided Brachial Plexus Block

Completed·HHillel Yaffe Medical Center·N/A·NCT01442558·101 enrolled

Total Shoulder Arthroplasty2 trials

Postoperative Pain Control in Total Shoulder Arthroplasty

Completed·SScripps Clinic·Phase 4·NCT05068960·100 enrolled

Liposomal Bupivacaine Versus Non-liposomal Bupivacaine for Total Shoulder Arthroplasty

Completed·UUniversity of Virginia·Phase 3·NCT04974385·80 enrolled

Local Anesthesia2 trials

Bupivacaine Versus Lidocaine Local Anesthesia

Completed·UUniversity of British Columbia·Phase 4·NCT01751347·135 enrolled

Bupivacaine Alone vs Bupivacaine With Tramadol in Local Anesthesia Procedures

Completed·JJinnah Postgraduate Medical Centre·Phase 3·NCT07469826·100 enrolled

Pain Control2 trials

Preoperative Levator Ani Muscle Injection and Pudendal Nerve Block for Pain Control After Vaginal Reconstructive Surgery

Completed·—·Phase 1/2·NCT03040011·79 enrolled

Hip Arthroscopy Pain Control Randomized Control Trial (RCT)

Completed·WWalter Reed National Military Medical Center·Phase 4·NCT02947178·74 enrolled

Thoracic Paravertebral Block2 trials

Pain Control After Open Radical Nephrectomy: Thoracic Paravertebral Block Versus External Oblique Intercostal Block

Completed·HHacettepe University·N/A·NCT07071012·98 enrolled

Postoperative Analgesic Effects of Using Dexmedetomidine for Ultrasound Guided Thoracic Paravertebral Block

Completed·TTC Erciyes University·Phase 4·NCT02544893·93 enrolled

Labor Analgesia2 trials

Programmed Intermittent Epidural Bolus for Labor Analgesia During First Stage of Labor-3

Completed·SSamuel Lunenfeld Research Institute, Mount Sinai Hospital·N/A·NCT02887222·40 enrolled

PIEB vs CEI for Labor Analgesia: An MLAC Study

Terminated·SStanford University·Phase 4·NCT02573597·31 enrolled

Peripheral Nerve Block2 trials

Systemic Steroids for Peripheral Nerve Blocks

Completed·WWake Forest University Health Sciences·Phase 4·NCT02464176·115 enrolled

Perineural Steroids for Peripheral Nerve Blocks

Completed·WWake Forest University Health Sciences·Phase 4·NCT02462148·85 enrolled

Cesarean Section2 trials

Combined Spinal-epidural Anesthesia for Cesarean Section Without Prophylactical Prehydration and Vasopressors

Unknown status·SShenzhen People's Hospital·N/A·NCT03497364·930 enrolled

Preventive Intramuscular Phenylephrine in Elective Cesarean Section Under Spinal Anesthesia

Completed·XXuzhou Medical University·N/A·NCT03507387·99 enrolled

Hernia2 trials

Post-operative Pain Control-TAP Block Using Exparel vs. Marcaine for Hernia Repairs

Active, not recruiting·LLeslie Son·Phase 1·NCT05177991·200 enrolled

Study to Evaluate Reduction in Pain After Laparoscopic Hernia Repair With Mesh Soaked in Bupivacaine Solution

Unknown status·—·N/A·NCT03035617·100 enrolled

Enrolling by invitation·WWashington University School of Medicine·Phase 4·NCT07280195·86 enrolled

Spinal Fusion1 trial

Epidural and Intravenous Patient-Controlled Analgesia Following Lumbar Spinal Fusion Surgery

Terminated·UUniversity of Texas Southwestern Medical Center·Phase 4·NCT03115151·46 enrolled

Postoperative Pain Management1 trial

COMPARISON OF INTRAOPERATIVE LOCAL ANESTHETIC APPLICATIONS IN POSTOPERATIVE PAIN MANAGEMENT IN LAPAROSCOPIC CHOLECYSTECTOMY PATIENTS

Completed·FFatih Sultan Mehmet Training and Research Hospital·Phase 4·NCT03790007·3 enrolled

Intraperitoneal1 trial

A Study to Determine the Effectiveness of Utilizing Intraperitoneal Bupivacaine

Completed·MMetro Health, Michigan·N/A·NCT03004222·137 enrolled

Inguinal hernia1 trial

Ultrasound-guided Ilioinguinal-iliohypogastric Block for Inguinal Hernia Repair

Unknown status·—·Phase 4·NCT01326039·60 enrolled

Cerebral Palsy1 trial

Popliteal Block for Postoperative Pain in Knee-ankle Soft Tissue Surgery in Cerebral Palsy

Completed·—·N/A·NCT02507700·60 enrolled

Extremity1 trial

Single Shot Exparel vs Catheters in Lower Extremity Trauma

Recruiting·GGeorge Washington University·Phase 4·NCT07221019·90 enrolled

Hip Fracture1 trial

Obturator and Femoral Nerve Block in Patients With Hip Fracture

Unknown status·UUniversity of Aarhus·Phase 4·NCT02540837·90 enrolled

GAN1 trial

Sphenopalatine Ganglion Blocks RCT

Completed·UUniversity of California, San Francisco·Phase 4·NCT03666663·10 enrolled

Spine Surgeries1 trial

Dexamethasone Plus Bupivacaine Versus Bupivacaine in Bilateral Trans-incisional Paravertebral Block in Lumbar Spine Surgeries .

Completed·—·N/A·NCT04783194·50 enrolled

Interscalene Brachial Plexus Block1 trial

Comparison Between Perineural and Systemic Effect of Dexamethasone for Interscalene Brachial Plexus Block.

Unknown status·HHillel Yaffe Medical Center·N/A·NCT02190760·90 enrolled

Migraine1 trial

Greater Occipital Nerve Block With Bupivacaine for Acute Migraine

Completed·MMontefiore Medical Center·Phase 3·NCT02665273·28 enrolled

Video-Assisted Thoracoscopic Surgery1 trial

Long Thoracic Nerve Blockade for Pain Treatment After Video-Assisted Thoracoscopic Surgery

Unknown status·—·N/A·NCT03483415·60 enrolled

Local Infiltration1 trial

Ultrasound Guided Local Infiltration Analgesia for Hip Arthroscopy

Terminated·TTrinity Health Of New England·N/A·NCT01907191·23 enrolled

Rib Fracture1 trial

Liposomal Bupivacaine Intercostal Nerve Block vs Thoracic Epidural for Regional Analgesia in Multiple Rib Fractures

Unknown status·CChadrick Evans·Phase 4·NCT03574376·258 enrolled

Spine Surgery1 trial

Caudal Epidural With Non Opioid Adjuvants in Lumbosacral Spine Surgery

Completed·—·N/A·NCT04411329·60 enrolled

Depth of Anesthesia1 trial

End Tidal Anesthetic Concentration in Different Anesthesia Techniques Where Depth of Anesthesia Adjusted With Entropy

Completed·IIstanbul University·N/A·NCT04203290·44 enrolled

Open Heart Surgery1 trial

Transversus Thoracic Muscle Plane Block for Open Heart Surgery

Completed·—·N/A·NCT04094532·48 enrolled

Total Hip Arthroplasty1 trial

Total Hip Arthroplasty: Multiple Blocks by UltraSound

Unknown status·—·N/A·NCT01276925·81 enrolled

Rhomboid Intercostal Block1 trial

Bilateral Rhomboid Intercostal Block for Perioperative Analgesia in Patients Undergoing Bilateral Reduction Mammoplasty

Completed·ZZagazig University·N/A·NCT06225895·72 enrolled

Total Hip Replacement1 trial

Minimal Opioid Use After Total Hip Replacement (THR)

Completed·HHospital for Special Surgery, New York·Phase 4·NCT03090152·180 enrolled

Ankle Block1 trial

Comparison Between Ultrasound-guided and Landmark-guided Ankle Blocks

Unknown status·HHillel Yaffe Medical Center··NCT01684774·100 enrolled

Hemorrhage1 trial

Effect of Bupivacaine-infused Fibrin Sealant Application on Post-tonsillectomy Pain & Hemorrhage

Terminated·IIndiana University School of Medicine·Phase 2·NCT02343263·18 enrolled

Laparoscopic Sleeve Gastrectomy1 trial

Efficacy Of Quadratus Lumborum II Block For Laparoscopic Sleeve Gastrectomy

Completed·IIcahn School of Medicine at Mount Sinai·Phase 4·NCT04073056·41 enrolled

Cardiovascular1 trial

Cardiovascular Safety Research: Bupivacaine With Vasoconstrictor Versus Ropivacaine in Brachial Plexus Block

Unknown status·UUniversity of Sao Paulo·Phase 4·NCT00523289·48 enrolled

Spinal Surgery1 trial

Ultrasound Guided Modified Thoracolumbar Interfascial Plane Block for Spinal Surgery

Completed·—·Phase 4·NCT03079076·40 enrolled

Pilot Study1 trial

The T REX Pilot Study: a Study to Investigate the Use of an Alternative Anaesthetic in Infants.

Completed·MMurdoch Childrens Research Institute·Phase 4·NCT02353182·60 enrolled

Breast Surgery1 trial

Effect of Addition of Fentanyl or Dexamethasone or Both to Bupivacaine in Paravertebral Block for Patients Undergoing Major Breast Surgery

Unknown status·—·N/A·NCT03480308·1 enrolled

Multimodal Analgesia1 trial

PECS Block vs. Multimodal Analgesia for Prevention of Persistent Postoperative Pain in Breast Surgery

Completed·WWashington University School of Medicine·Phase 2·NCT03084536·134 enrolled

Renal Transplant1 trial

Dual Transversus Abdominis Plane Block in Pediatric Renal Transplant: Effect on Pain Control

Completed·—·N/A·NCT02858622·44 enrolled

Mucositis1 trial

Local Anesthetic Treatment of Oral Pain in Patients With Mucositis

Completed·HHvidovre University Hospital·Phase 2·NCT02252926·70 enrolled

External Oblique Intercostal Plane Block1 trial

Dexmedetomidine and Ketamine as an Adjuvant in External Oblique Intercostal Plane Block for Post Thoracotomy Pain

Completed·TTanta University·N/A·NCT06331182·40 enrolled

Epilepsy1 trial

Conscious Sedation for Epilepsy Surgery

Completed·MMenoufia University·N/A·NCT02988050·60 enrolled

Caesarean Section1 trial

Spinal Anesthesia in Caesarean Section

Unknown status·—··NCT03743870·250 enrolled

Pelvic Organ Prolapse1 trial

Intraperitoneal Bupivacaine for Pelvic Organ Prolapse

Completed·IIndiana University·Phase 4·NCT06120530·91 enrolled

Pain1 trial

The PAIN (Pelvic Area Injection for Numbness) Study

Recruiting·MMontefiore Medical Center·Phase 4·NCT05972681·100 enrolled

Cholecystectomy1 trial

Randomized Control Trial of Intraperitoneal Bupivacaine During Cholecystectomy

Completed·UUniversity Hospitals Coventry and Warwickshire NHS Trust·N/A·NCT01528722·42 enrolled

Congenital hip dislocation1 trial

Pericapsular Nerve Group (PENG) Block for Congenital Hip Dislocation Surgery

Completed·—·N/A·NCT04212039·48 enrolled

Caudal Anesthesia1 trial

Clonidine and Morphine in Caudal Anesthesia

Completed·FFederal University of Minas Gerais·Phase 1/2·NCT00672347·80 enrolled

Serratus Anterior Plane Block1 trial

US-Guided Serratus Anterior Plane Block Versus Thoracic Epidural in Patients Undergoing Thoracotomy

Completed·NNational Cancer Institute, Egypt·N/A·NCT05672394·74 enrolled

Breast Reconstruction1 trial

The Use of Pecs Blocks in Combination With Exparel in Breast Reconstruction Surgery

Completed·NNorthwestern University·Phase 3·NCT05171179·60 enrolled

Pancreatic Cancer1 trial

EUS Guided Neurolysis Celiac Block w/wo Bupivacaine in Patient Being Treated Palliatively for Pancreatic Cancer

Terminated·—·N/A·NCT02682082·22 enrolled

ESS1 trial

Success of External Cephalic Version Study

Terminated·IIcahn School of Medicine at Mount Sinai·Phase 4·NCT03106753·34 enrolled

Blood Pressure1 trial

Decision Support for Intraoperative Low Blood Pressure

Completed·VVanderbilt University Medical Center·N/A·NCT02726620·22,435 enrolled

Peripheral Nerve Stimulation1 trial

Peripheral Nerve Stimulation of Genicular Nerves Versus Conventional Therapy With Intra-articular Steroid Injection for Chronic Knee Pain: A Prospective, Randomized Pilot Study

Recruiting·MM.D. Anderson Cancer Center·N/A·NCT06004882·45 enrolled

Laparoscopic1 trial

Transversus Abdominis Plan Block, Ultrasound or Laparoscopic?

Completed·—·N/A·NCT04634721·60 enrolled

Safety and Efficacy1 trial

Evaluate the Safety and Efficacy of EXPAREL When Administered Via Infiltration Into the TAP vs. Bupivacaine Alone in Subjects Undergoing Elective C-Sections

Completed· Pacira Pharmaceuticals, Inc logo

Pacira Pharmaceuticals, Inc·Phase 4·NCT03176459·186 enrolled

Delirium1 trial

Delirium in Elderly Patients With Trauma of the Hip

Terminated·—·Phase 4·NCT02689024·239 enrolled

Knee Arthroplasty1 trial

A Clinical Trial of Two Periarticular Multimodal Drug Injections in Total Hip and Knee Arthroplasty

Completed·KKootenai Health·Phase 4·NCT02543801·239 enrolled

Side Effects1 trial

Optimizing Dose of Bupivacaine in Combined Spinal Epidurals To Reduce Side Effects

Completed·SSt. Luke's-Roosevelt Hospital Center·N/A·NCT02159807·170 enrolled

Abdominal Surgery1 trial

Immune Response of Caudally Administrated Tramadol In Pediatric Lower Abdominal Surgery

Completed·—·Phase 2·NCT02703415·60 enrolled

Low back pain1 trial

Clinical Trial Examining the Short and Long-term Effect of Myofascial Trigger Points Injection in Low Back Pain Patients

Completed·—·Phase 2·NCT01520415·40 enrolled

Vaginal Delivery1 trial

Lignocaine vs Bupivacaine Infiltration for Postpartum Perineal Pain After Vaginal Delivery With Episiotomy in Primigravidae

Recruiting·—·N/A·NCT06568289·60 enrolled

Methylprednisolone1 trial

Triamcinolone Versus Methylprednisolone in Transversus Abdominis Plane Block

Completed·Gghada fouad·Phase 2/3·NCT04480775·84 enrolled

Breast Cancer1 trial

Nerveblocks for Persistent Pain After Breast Cancer Surgery

Unknown status·KKenneth Geving Andersen·Phase 3·NCT02336529·48 enrolled

Infiltration1 trial

Peritubal Infiltration of Bupivacaine in PCNL

Unknown status·IIndus Hospital and Health Network·Phase 4·NCT02198027·68 enrolled

Arthroscopic Shoulder Surgeries1 trial

Pain Control After Arthroscopic Shoulder Surgeries

Completed·TTanta University·N/A·NCT05686395·90 enrolled

Tics1 trial

Pharmacokinetics of BPV Following Bilateral US-guided TAP Block for C-section

Completed·UUniversity Tunis El Manar··NCT03006042·17 enrolled

Supraclavicular Brachial Plexus Block1 trial

Effect of the Addition of Dexmedetomidine to Bupivacaine During Supraclavicular Brachial Plexus Blockade

Completed·TTC Erciyes University·Phase 4·NCT02049970·44 enrolled

Atrial Fibrillation1 trial

Study to Evaluate the Effectiveness of SGB in Preventing Post-op Atrial Fibrillation

Withdrawn·—·Phase 4·NCT03269383

Diabetic Foot1 trial

Safety and Efficacy of Three Local Block Techniques for Diabetic Foot Surgery

Unknown status·—·N/A·NCT03155568·90 enrolled

Femur Fracture1 trial

Fascia Iliaca Compartment Block for Proximal-end Femur Fractures

Completed·MMansoura University·N/A·NCT02696915·60 enrolled

Abdominal Surgeries1 trial

Comparison of Pain ReliefofBupivacaineWith Dexmedetomidine and Bupivacaine Alone in TransversusAbdominisPlane Block For Postoperative Anelgesia in Patients Undergoing Abdominal Surgeries

Unknown status·SSheikh Zayed Medical College·Phase 1·NCT05244252·80 enrolled

Hypospadias1 trial

Caudal Combination of Dexamethasone and/or Dexmedetomidine to Bupivacaine in Pediatric Hypospadias Surgery

Completed·—·Phase 1·NCT03261921·63 enrolled

Regional Anesthesia1 trial

Comparative Analysis of Ultrasound-Guided Versus Landmark-Based Techniques for Regional Anesthesia in Egyptian Patients

Not yet recruiting·—·N/A·NCT06756347·100 enrolled

Ketorolac1 trial

Evaluating Pain Outcomes of Ketorolac Administration in Children Undergoing Circumcision

Completed·—·Phase 1·NCT02973958·30 enrolled

Functional Endoscopic Sinus Surgery1 trial

Regional Anesthesia to Reduce Opioid Use Following Functional Endoscopic Sinus Surgery

Completed·UUniversity of Alabama at Birmingham·Phase 4·NCT03757715·46 enrolled

Femoral Nerve Block1 trial

Ultrasound Guided Femoral Nerve Block

Completed·—·N/A·NCT02381717·44 enrolled

Postoperative Quality of Recovery1 trial

Postoperative Quality of Recovery After Transurethral Resection of the Bladder

Unknown status·—·N/A·NCT02534623·70 enrolled

Tonsillectomy1 trial

Peri Tonsillar Infiltration of Ketamine or Bupivacaine for Post Tonsillectomy Analgesia

Completed·SSohag University·Phase 4·NCT05341323·80 enrolled

Multimodal Pain Management1 trial

Multimodal Pain Management Following Primary TKA

Terminated·UUniversity of Utah·Phase 1·NCT02369523·84 enrolled

Superficial Cervical Plexus Block1 trial

Superficial Cervical Plexus Block and Quality of Recovery After Thyroidectomy

Completed·YYale University·Phase 2·NCT06002152·160 enrolled

Neostigmine1 trial

Epidural Neostigmine for Labor Pain

Completed·WWake Forest University·Phase 1·NCT00779467·200 enrolled

Knee Arthroscopy1 trial

Spinal Anaesthesia for Knee Arthroscopy: Does Lignocaine Shorten the Effect of Bupivacaine

Completed·—·Phase 4·NCT01245868·60 enrolled

ACL Reconstruction1 trial

A Novel Analgesia Technique for ACL Reconstruction

Completed·HHospital for Special Surgery, New York·Phase 4·NCT03292926·78 enrolled

Hyperbaric Bupivacaine1 trial

Hyperbaric Bupivacaine Versus Hyperbaric Prilocaine in Spinal Anaesthesia

Active, not recruiting·NNational University Hospital, Singapore·Phase 4·NCT07329582·50 enrolled

Sinus Surgery1 trial

Ropivacaine and Bupivacaine in Sphenopalatine Ganglion Block in Sinus Surgery

Completed·PPost Graduate Institute of Medical Education and Research, Chandigarh·Phase 3·NCT03013361·60 enrolled

Scoliosis1 trial

Continuous Local Infusion of Anesthetic at the Incisional Site for Scoliosis Surgery

Completed·SShriners Hospitals for Children·Phase 4·NCT00508066·60 enrolled

Facial Pain1 trial

Ultrasound Guided Trigeminal Nerve Block for Typical or Atypical Facial Pain

Completed·NNorthwestern University·Phase 4·NCT02024724·60 enrolled

Hemodynamic1 trial

Postoperative Hemodynamics Comparison After High Spinal Block With or Without Intrathecal Morphine.

Unknown status·PPost Graduate Institute of Medical Education and Research, Chandigarh·Phase 1·NCT02825056·60 enrolled

Unspecified1 trial

PEC Block II in Mammoplasty Surgeries

Unknown status·FFederal University of São Paulo·N/A·NCT03488888·40 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

BUPIVACAINE HYDROCHLORIDE

NDA NDA018053

Jan 1, 1982

MARCAINE HYDROCHLORIDE

NDA NDA016964

Jan 1, 1982

SENSORCAINE

NDA NDA018304

May 4, 1984

MARCAINE

NDA NDA018692

Sep 3, 1992

BUPIVACAINE HYDROCHLORIDE KIT

NDA NDA019978

Oct 28, 2011

EXPAREL

NDA NDA022496

Aug 28, 2020

XARACOLL

NDA NDA209511

Feb 1, 2021

POSIMIR

NDA NDA204803

Sources

References

[1]
ClinicalTrials.gov — 618 trial records for Bupivacaine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Marcaine drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Bupivacaine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Bupivacaine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA204803). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Marcaine. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Innocoll company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Sodium Channel Protein Type IV Alpha Subunit Blocker[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: IInnocoll

Patent Landscape[6]

Patent Cliff

May 20, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

RE47826May 20, 2029

11746141Jan 9, 2033

11400019Jan 12, 2041

11771624Jan 12, 2041

11179336Jan 22, 2041

20 more patents

11426348Jan 22, 2041

12296047Jan 22, 2041

11452691Jan 22, 2041

11819575Jan 22, 2041

11033495Jan 22, 2041

12144890Jan 22, 2041

11357727Jan 22, 2041

11311486Jan 22, 2041

11278494Jan 22, 2041

11304904Jan 22, 2041

11819574Jan 22, 2041

11925706Jan 22, 2041

12151024Jan 22, 2041

11931459Mar 17, 2042

11918565Feb 2, 2043

12226610Feb 2, 2043

12251468Jul 2, 2044

12156940Jul 2, 2044

12370142Jul 2, 2044

12318483Jul 2, 2044

Marcaine

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Q3 2027

Trials by Indication[1]

Liposomal Bupivacaine12 trials

Bupivacaine9 trials

Total Knee Arthroplasty7 trials

Dexamethasone7 trials

Nerve Block6 trials

Post Operative Pain6 trials

Local Anesthetic5 trials

Cesarean Delivery4 trials

Spinal Anesthesia4 trials

Erector Spinae Plane Block4 trials

Dexmedetomidine4 trials

Postoperative Pain Control3 trials

Hysterectomy3 trials

Postoperative Analgesia3 trials

Interscalene Block3 trials

Laparoscopic Cholecystectomy3 trials

Analgesia2 trials

Analgesic Efficacy2 trials

Concentration2 trials

Quadratus Lumborum Block2 trials

Surgery2 trials

Mastectomy2 trials

Colorectal Surgery2 trials

Amputation2 trials

Ultrasound2 trials

Total Shoulder Arthroplasty2 trials

Local Anesthesia2 trials

Pain Control2 trials

Thoracic Paravertebral Block2 trials

Labor Analgesia2 trials

Peripheral Nerve Block2 trials

Cesarean Section2 trials

Hernia2 trials

Hemodynamic Stability1 trial

Opioid Use Disorder1 trial

Shoulder Arthroplasty1 trial

Spinal Fusion1 trial

Postoperative Pain Management1 trial

Intraperitoneal1 trial

Inguinal hernia1 trial

Cerebral Palsy1 trial

Extremity1 trial

Hip Fracture1 trial

GAN1 trial

Spine Surgeries1 trial

Interscalene Brachial Plexus Block1 trial

Migraine1 trial

Video-Assisted Thoracoscopic Surgery1 trial

Local Infiltration1 trial

Rib Fracture1 trial

Spine Surgery1 trial

Depth of Anesthesia1 trial

Open Heart Surgery1 trial

Total Hip Arthroplasty1 trial

Rhomboid Intercostal Block1 trial

Total Hip Replacement1 trial

Ankle Block1 trial

Hemorrhage1 trial

Laparoscopic Sleeve Gastrectomy1 trial

Cardiovascular1 trial

Spinal Surgery1 trial

Pilot Study1 trial

Breast Surgery1 trial

Multimodal Analgesia1 trial

Renal Transplant1 trial

Mucositis1 trial

External Oblique Intercostal Plane Block1 trial

Epilepsy1 trial

Caesarean Section1 trial

Pelvic Organ Prolapse1 trial

Pain1 trial